Events

Alerta De Seguridad para 10% Neutral Buffered Formalin

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Thermo Scientific Richard-Allan Scientific.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2014-10-17
  • Fecha de publicación del evento
    2014-10-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141017.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: thermo scientific richard-allan scientific 10% neutral buffered formalin the u.S. food and drug administration (fda) posted a medical device safety alert concerning 10% neutral buffered formalin (nbf), manufactured by thermo scientific richard-allan scientific. the product details are as follows: cardinal health prefilled buffered 10% formalin (product code: c4320-450b; lot no.: 300403); richard-allan scientific specimen transportation system (product code: 53151 and 534801; lot no.: 300143 and 296986); richard-allan scientific 10% nbf (product code: 51401 and lc-0060; lot no.: 300649 and 300445); richard-allan scientific bio-tite specimen containers (product code: 59601; lot no.: 300233); protocol 10% nbf product (product code: 426-796; lot no.: 298987) the affected lots could have nbf concentrations that are lower or higher than the desired specifications. for details, please refer to the fda website http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=69276&w=10152014??eng if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 17 october 2014.

Device

10% Neutral Buffered Formalin

Manufacturer

Thermo Scientific Richard-Allan Scientific